The present invention is compatible and complementary with the elements disclosed in the following pending applications: “Medical System Having Improved Telemetry,” filed Jul. 19, 1999, Ser. No. 09/356,340; “System and Method for Transferring Information Relating to an Implantable Medical Device to a Remote Location,” filed on Jul. 21, 1999, Ser. No. 09/358,081; “Apparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,” filed on Oct. 26, 1999, Ser. No. 09/426,741; “Tactile Feedback for Indicating Validity of Communication Link with an Implantable Medical Device,” filed Oct. 29, 1999, Ser. No. 09/430,708; “Apparatus and Method for Automated Invoicing of Medical Device Systems,” filed Oct. 29, 1999, Ser. No. 09/429; “Apparatus and Method for Remote Self-Identification of Components in Medical Device Systems,” filed Oct. 29, 1999, Ser. No. 09/429,956; “Apparatus and Method to Automate Remote Software Updates of Medical Device Systems,” filed Oct. 29, 1999, Ser. No. 09/429,960; “Method and Apparatus to Secure Data Transfer From Medical Device Systems,” filed Nov. 2, 1999, Ser. No 09/431,881 “Implantable Medical Device Programming Apparatus Having An Auxiliary Component Storage Compartment,” filed Nov. 4, 1999, Ser. No. 091433,477; “Remote Delivery Of Software-Based Training For Implantable Medical Device Systems,” filed Nov. 10, 1999, Ser. No. 09/437,615; “Apparatus and Method for Remote Therapy and Diagnosis in Medical Devices Via Interface Systems,” filed Dec. 14, 1999, Ser. No. 09/460,580; “Virtual Remote Monitor, Alert, Diagnostics and Programming For Implantable Medical Device Systems” filed Dec. 17, 1999, Ser. No. 09/466,284; “Instrumentation and Software for Remote Monitoring and Programming of Implantable Medical Devices (IMDs), filed Dec. 21, 1999, Ser. No. 60/172,937; “Application Proxy For Telecommunication-enabled Remote Medical Access Instruments,” filed Dec. 4, 1999, Ser. No. 60/173,081; “Information Network Scheme For Interrogation Of Implantable Medical Devices (IMDs),” filed Dec. 24, 1999, Ser. No. 60/173,064; “Medical Device GUI For Cardiac Electrophysiology Display And Data Communications,” filed Dec. 24, 1999, Ser. No. 60/173,065; “Integrated Software System For Implantable Medical Device Installation And Management,” filed Dec. 24, 1999, Ser. No. 60/173,082; “Dynamic Bandwidth Monitor And Adjuster For Remote Communications With A Medical Device,” filed Dec. 24, 1999, Ser. No. 60/173,083 “Large-Scale Processing Loop For Implantable Medical Devices (IMDs),” filed Dec. 24,1999, Ser. No. 60/173,079; “Chronic Real-Time Information Management Systems For Implantable Medical Devices (LMDs),” filed Dec. 24,1999, Ser. No. 60/173,062; “Automatic Voice and Data Recognition For Medical Device Instrument Systems,” filed Dec. 24, 1999, Ser. No. 60/173,071 “Central Switchboard to Facilitate Remote Collaboration With Medical Instruments,” filed Dec. 24, 1999, Ser. No. 60/173,080; which are all incorporated by reference herein in their entireties.
In the traditional provision of any medical services, including routine check-ups and monitoring, a patient is required to physically present themselves at a provider's office or other clinical setting. In emergency situations, health care providers may travel to a patient's location, typically to provide stabilization during transport to a clinical setting, e.g., an emergency room. In some medical treatment applications, accepted medical practice for many procedures will naturally dictate physical proximity of medical providers and patients. However, the physical transport of patients to clinical settings requires logistical planning such as transportation, appointments, and dealing with cancellations and other scheduling complications. As a result of such logistical complications, patient compliance and clinician efficiency may suffer. In certain situations, delays caused by patient transport or scheduling may result in attendant delays in detection of medical conditions such as life-threatening situations. It is desirable, therefore, to minimize situations in which the physical transport of a patient to a clinical setting is required. It may also be desirable to minimize the extent to which an patient or patient information must be considered by a clinician at a particular time, i.e. during an appointment.
After the implantation of an IMD, for example, a cardiac pacemaker, clinician involvement with respect to the IMD has typically only begun. The IMD usually cannot be merely implanted and forgotten, but must be monitored for optimal results, and may require adjustment of certain parameters or settings, or even replacement, in response to or in anticipation of changes in patient condition or other environmental factors, or based on factors internal to the device. IMDs may also contain logic devices such as digital controllers, which may need to undergo firmware or software upgrades or modifications. In addition, information about the IMD may be gathered for treatment or research purposes. For example, many IMDs are capable of storing certain state information or other data regarding their operation internally.
While some data regarding IMD operation may be stored internally to the device, human physiological systems are very complex and nonlinear, i.e., exhibiting effects that may appear surprising or chaotic based on predictions using simple periodic or linear models. IMDs are designed to dynamically interact with these physiological systems on the fly, but often can only work with simplified models or the most elemental of the systems. The limitations of IMDs in interacting with physiological systems are twofold: There may be an incomplete understanding of the characteristics of the physiological system in all of its nonlinear complexity. However, there may be simply a lack of raw computing power on the part of the IMD.
Despite the limitations of IMDs with regard to processing power, IMDs are in a unique position to monitor physiological systems continuously. High-resolution data can be collected, but implantable devices may only store and process limited amounts of complex physiological and medical data.
Computing power (processor capability, memory, and adequate power supply) is abundantly available in the non-implantable (“external”) world. The computing industry is still following Moore's Law (stating that transistor density will double every 18 months), delivering increasingly sophisticated computing devices yearly, and some of these gains accrue to the computer power of IMDs. However, frequent upgrading and replacement of IMDs based on more powerful models subjects a patient to additional stresses, and additional costs are imposed on the patient or health care system.
Models of physiological systems researched and developed on powerful external computing systems are often valuable in the medical world, but are not suitable for use in implantable medical devices. Cases involving long-term monitoring or forecasting are particularly well suited to external computing systems. External systems can deal with the complexity and amount of data, but because of their size, are of course not suitable for implantation.
Prior art methods of clinical services, particularly IMD monitoring and adjustment, are generally limited to in-hospital procedures or other scenarios involving patient transportation to a clinical setting. For example, if a physician needs to review the performance parameters of an IMD in a patient, it is likely that the patient has to go to the clinic. Further, if the medical conditions of a patient with an IMD warrant a continuous monitoring or adjustment of the device, the patient would have to stay in a hospital indefinitely. Such a continued treatment plan poses both economic and social problems. Under the prior art, as the segment of the population with IMDs increases, many more hospitals and clinics, and attendant clinicians and service personnel will be needed to provide in-hospital service for the patients, thus escalating the cost of healthcare. Additionally, the patients will be unduly restricted and inconvenienced by the need to either stay in the hospital or make very frequent visits to a clinic.
Yet another condition of the prior art practice requires that a patient visit a clinic center for occasional retrieval of data from the implanted device to assess the operations of the device and gather patient history for both clinical and research purposes. Such data is acquired by having the patient in a hospital/clinic to download the stored data from the IMD. Depending on the frequency of data collection, this procedure may pose serious difficulty and inconvenience for patients who live in rural areas or have limited mobility. Similarly, in the event a need arises to upgrade the software of an implantable medical device, the patient will be required to come into the clinic or hospital to have the upgrade installed.
Further, it is a typical medical practice to keep an accurate record of past and contemporaneous procedures relating to an IMD uplink with, for example, an IMD programmer, i.e. a computer capable of making changes to the firmware or software of an IMD. It is typically desired that the report contain the identification of all the medical devices involved in any interactive procedure. Specifically, all peripheral and major devices that are used in downlinking to the IMD may be reported. Currently, such procedures are manually reported, and require an operator or a medical person to manually enter data during each procedure. One of the limitations of such manual reporting procedures is the possibility for human error in data entry, thus motivating rechecking of the data to verify accuracy. Generally, the use of human clinicians to analyze data and implement changes in device therapy can result in inefficiencies and errors.
Yet a further condition of the prior art relates to the interface between a human operator and a programmer system. Generally, a medical device manager/technician, should be trained on the clinical and operational aspects of the programmer. Under current practices, an operator may attend a class/session sponsored by a clinic, hospital, or the manufacturer to successfully manage a programmer-IMD procedure. Further, the operator will preferably keep abreast of new developments and new procedures in the management, maintenance and upgrade of the IMD. Accordingly, it is desirable that operators of programmers, IMDs, and related medical devices receive regular training or information about the IMDs they work with. This information will preferably be widely distributed, because IMDs, programmers and related medical devices are distributed throughout the world. Further, the number of people having implanted medical devices has been increasing over the last few years, with an attendant increase in operator personnel. The total effect of these developments is a widely dispersed and large body of operators. Thus, it is desirable to have a high efficiency communications system that would enhance data communications, both between the IMDs and medical instruments, such as programmers; and between operators and entities providing IMD updates and education such as manufacturers.
A further limitation of the prior art relates to the management of multiple medical devices in a single patient. Advances in modern patient therapy and treatment have made it possible to implant a number of devices in a patient. For example, IMDs such as a defibrillator or a pacer, a neural implant, a drug pump, a separate physiologic monitor and various other IMDs may be implanted in a single patient. To successfully manage the operations and assess the performance of each device in a patient with multi-implants requires a continuous update and monitoring of the devices.
Further, it may be preferred to have an operable communication between the various implants to provide a coordinated clinical therapy to the patient. Thus, there is a need to monitor the IMDs and the programmer on a regular, if not a continuous, basis to ensure optimal patient care. In the absence of other alternatives, this imposes a great burden on the patient if a hospital or clinic is the only center where the necessary upgrade, follow up, evaluation and adjustment of the IMDs could be made. Further, even if feasible, the situation would require the establishment of multiple service areas or clinic centers to support the burgeoning number of multi-implant patients worldwide.
Generally, IMDs of the prior art are limited in that the features and functions of implantable medical device may not take full advantage of the complex modeling of physiologic systems that are being continually established; these devices simply lack the processing power to perform the required calculations, and may be expected to lack this power indefinitely. Accordingly, mankind's ever-increasing knowledge of physiologic systems must be simplified considerably in order to be implemented within an IMD. It would be desirable to provide a system by which the complex modeling of physiologic systems could be brought to bear in IMD instruction in order to improve patient outcomes.